Seres Therapeutics Announces Initiation of SER-287 Phase 2B ECO-RESET Clinical Study for Ulcerative Colitis
– Recent FDA correspondence indicates this SER-287 Phase 2B study may support Biologics License Application (BLA) –
– Company has received
“Advancing SER-287 into a late stage Phase 2B trial is a significant
achievement,” said
The SER-287 Phase 2B ECO-RESET study has been designed as a pivotal
trial. The Company recently obtained feedback from the
The Phase 2B study is a three-arm placebo-controlled trial of approximately 200 patients with active mild-to-moderate ulcerative colitis. Two groups of patients will receive different doses of SER-287, both following pretreatment with a short course of oral vancomycin. A third study arm will receive placebo. The study’s primary endpoint will evaluate clinical remission measured after 10 weeks of SER-287 administration. Endoscopic improvement will be measured as a secondary efficacy measure.
About SER-287
SER‐287 is a biologically sourced oral capsule
developed using Seres’ proprietary microbiome therapeutics platform. The
SER-287 Phase 2b study clinicaltrials.gov identifier is NCT03759041.
A SER-287 Phase 1b placebo-controlled induction study in patients with
mild-to-moderate active ulcerative colitis demonstrated a dose-dependent
improvement of clinical remission rates and endoscopic scores and a
favorable tolerability profile.
About Ulcerative Colitis
Ulcerative colitis is a serious
chronic condition affecting approximately 700,000 individuals in the
About Seres Therapeutics
Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including the ability of ECO-RESET to support SER-287 approval.
These forward-looking statements are based on management’s current
expectations. These statements are neither promises nor guarantees, but
involve known and unknown risks, uncertainties and other important
factors that may cause our actual results, performance or achievements
to be materially different from any future results, performance or
achievements expressed or implied by the forward-looking statements,
including, but not limited to, the following: we have incurred
significant losses, are not currently profitable and may never become
profitable; our need for additional funding; our limited operating
history; our unproven approach to therapeutic intervention; the lengthy,
expensive, and uncertain process of clinical drug development; our
reliance on third parties and collaborators to conduct our clinical
trials, manufacture our product candidates, and develop and
commercialize our product candidates, if approved; our ability to retain
key personnel and to manage our growth; and our management and principal
stockholders have the ability to control or significantly influence our
business. These and other important factors discussed under the caption
“Risk Factors” in our Quarterly Report on Form 10-Q filed with the
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Source:
IR or PR Contact:
Carlo Tanzi,
Ph.D., Seres Therapeutics, 617-203-3467
Vice President, Investor
Relations and Corporate Communications
ctanzi@serestherapeutics.com